FDA 483 - IVF-PGD LAB LLC - February 13, 2019

An FDA inspection of IVF-PGD LAB LLC in Chicago, IL, identified one observation related to the labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to prominently label cryopreserved semen donor files with appropriate warning statements when donor eligibility determinations had not been performed. This indicates a deficiency in HCT/P labeling practices.